This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Change to the in-process sampling requirements of several extruded tubing components.
Device | INTEGRITY CORONARY STENT SYSTEMS |
Classification Name | Stent, Coronary |
Generic Name | Stent, Coronary |
Applicant | MEDTRONIC IRELAND |
Date Received | 2013-04-08 |
Decision Date | 2013-05-08 |
PMA | P030009 |
Supplement | S064 |
Product Code | MAF |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | MEDTRONIC IRELAND parkmore Business Park West galway |
Supplement Number | Date | Supplement Type |
---|---|---|
P030009 | Original Filing | |
S107 | 2022-03-23 | 30-day Notice |
S106 | 2021-10-28 | 30-day Notice |
S105 | ||
S104 | ||
S103 | 2021-04-23 | Special (immediate Track) |
S102 | 2021-04-12 | 30-day Notice |
S101 | ||
S100 | 2021-03-04 | 30-day Notice |
S099 | 2021-01-25 | 30-day Notice |
S098 | 2020-10-26 | 30-day Notice |
S097 | 2020-07-10 | Normal 180 Day Track No User Fee |
S096 | 2020-05-04 | 30-day Notice |
S095 | 2018-09-24 | 30-day Notice |
S094 | 2018-09-24 | 30-day Notice |
S093 | 2017-11-20 | 30-day Notice |
S092 | 2017-07-03 | Real-time Process |
S091 | 2017-01-30 | 30-day Notice |
S090 | 2016-09-02 | 30-day Notice |
S089 | 2016-08-17 | 135 Review Track For 30-day Notice |
S088 | 2016-07-13 | 30-day Notice |
S087 | 2016-05-16 | 30-day Notice |
S086 | 2016-04-22 | 135 Review Track For 30-day Notice |
S085 | 2016-03-14 | 30-day Notice |
S084 | ||
S083 | 2016-01-29 | 30-day Notice |
S082 | 2015-08-17 | 30-day Notice |
S081 | 2015-05-14 | 30-day Notice |
S080 | 2015-03-20 | 135 Review Track For 30-day Notice |
S079 | 2014-07-02 | 30-day Notice |
S078 | 2014-04-25 | 30-day Notice |
S077 | 2014-04-03 | 30-day Notice |
S076 | 2014-03-18 | 30-day Notice |
S075 | 2014-02-18 | 30-day Notice |
S074 | 2014-02-03 | Special (immediate Track) |
S073 | 2013-12-16 | 30-day Notice |
S072 | 2013-11-22 | 30-day Notice |
S071 | 2013-11-18 | 30-day Notice |
S070 | 2013-11-15 | 30-day Notice |
S069 | 2013-09-26 | 30-day Notice |
S068 | 2013-09-26 | 30-day Notice |
S067 | 2013-08-19 | 30-day Notice |
S066 | 2013-08-02 | 30-day Notice |
S065 | 2013-07-01 | 30-day Notice |
S064 | 2013-04-08 | 30-day Notice |
S063 | 2013-03-14 | Special (immediate Track) |
S062 | 2012-12-17 | 30-day Notice |
S061 | 2012-03-22 | 135 Review Track For 30-day Notice |
S060 | 2011-09-26 | 30-day Notice |
S059 | ||
S058 | 2011-08-08 | Real-time Process |
S057 | 2011-07-05 | 30-day Notice |
S056 | 2011-06-29 | 30-day Notice |
S055 | 2011-04-15 | 30-day Notice |
S054 | 2011-04-11 | Real-time Process |
S053 | 2010-12-20 | 30-day Notice |
S052 | 2010-12-10 | 30-day Notice |
S051 | 2010-12-10 | 135 Review Track For 30-day Notice |
S050 | 2010-11-15 | 135 Review Track For 30-day Notice |
S049 | 2010-11-01 | 30-day Notice |
S048 | 2010-10-22 | 30-day Notice |
S047 | 2010-10-04 | 30-day Notice |
S046 | 2010-10-01 | 30-day Notice |
S045 | 2010-10-01 | 30-day Notice |
S044 | 2010-08-16 | 30-day Notice |
S043 | 2010-06-04 | 30-day Notice |
S042 | 2010-03-16 | 135 Review Track For 30-day Notice |
S041 | 2010-03-16 | 30-day Notice |
S040 | 2010-03-01 | 30-day Notice |
S039 | 2010-02-12 | Normal 180 Day Track |
S038 | 2009-12-24 | 135 Review Track For 30-day Notice |
S037 | 2009-11-09 | Normal 180 Day Track No User Fee |
S036 | 2009-10-13 | 30-day Notice |
S035 | 2009-08-28 | 30-day Notice |
S034 | 2009-03-23 | 30-day Notice |
S033 | 2009-02-04 | 30-day Notice |
S032 | 2008-12-22 | 30-day Notice |
S031 | 2008-12-22 | 30-day Notice |
S030 | 2008-12-12 | 30-day Notice |
S029 | 2008-11-17 | 30-day Notice |
S028 | 2008-11-05 | Normal 180 Day Track No User Fee |
S027 | 2008-10-27 | 30-day Notice |
S026 | 2008-07-16 | 135 Review Track For 30-day Notice |
S025 | 2008-05-28 | 135 Review Track For 30-day Notice |
S024 | 2008-05-23 | 30-day Notice |
S023 | 2008-05-01 | Normal 180 Day Track No User Fee |
S022 | 2008-04-21 | 30-day Notice |
S021 | 2008-03-31 | 135 Review Track For 30-day Notice |
S020 | 2008-03-31 | Normal 180 Day Track |
S019 | 2008-03-24 | 135 Review Track For 30-day Notice |
S018 | 2008-01-14 | 30-day Notice |
S017 | ||
S016 | 2007-10-09 | 30-day Notice |
S015 | 2007-08-01 | 30-day Notice |
S014 | 2007-08-01 | 30-day Notice |
S013 | 2007-08-01 | 135 Review Track For 30-day Notice |
S012 | ||
S011 | ||
S010 | ||
S009 | 2007-07-30 | 30-day Notice |
S008 | 2006-11-27 | Special (immediate Track) |
S007 | 2006-10-30 | 30-day Notice |
S006 | ||
S005 | 2006-07-18 | 30-day Notice |
S004 | 2005-11-30 | 30-day Notice |
S003 | 2005-08-29 | Real-time Process |
S002 | 2004-07-14 | Normal 180 Day Track |
S001 | 2004-02-05 | Real-time Process |